Efficiency and Safety of a Procedural Sedation by Propofol on Terminally Ill Patients With Refractory Pain

NCT02734511 | Completed Phase 3

• 1 other identifier: 16-AOI-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Relieving symptoms of patients hospitalized in a palliative care unit is a priority. Although they receive appropriate care, they may still experience pain refractory to analgesia or/and to conservative treatment during care procedures. For instance, pain can be caused by the bandaging of carcinological or ischemic wounds, or by the mobilization of traumatic injuries which cannot be specifically treated. Although these types of situations are rare, they remain unacceptable, especially at the end of life. According to current recommendations, a short-term sedation treatment can be administered although detailed procedures for this type of sedation have not been very much documented. In reality, midalozam is often used in those cases but it has drawbacks, which is why the investigators have looked into alternatives. Propofol, which is already widely used in anesthesia and emergency medicine to manage painful procedures, seems to be an interesting molecule because of its pharmacological properties. It allows to quickly reach deep sedation and thus obtain a certain level of comfort for the patient, but also ensures a prompt awakening as soon as care procedures are over, which limits respiratory side effects. The results from a preliminary study encouraged us to go further and to present a prospective study conducted in multiple centers in order to evaluate the efficiency and safety of a procedural sedation administered by trained doctors who are not anesthesiologists on terminally ill patients with refractory pain hospitalized in a palliative care unit.

Conditions

Refractory Pains

Outcome Measures

Primary Outcomes (2)

• success rate of care without severe pain for the patient

  Success is defined as the administration of care without severe pain for the patient

  from the beginning of sedation to 2 hours after sedation

• success rate of care without major side effects

  Major side effects are defined as ''Sentinel AEs'' by the World SIVA (Society of IntraVeinous Anesthesia) International Sedation Task Force

  from the beginning of sedation to 2 hours after sedation

Study Arms (1)

Drug: sedation with propofol

EXPERIMENTAL

induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h

Drug: sedation with propofol

Interventions

sedation with propofol DRUG

induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h

Drug: sedation with propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient hospitalized in the palliative care unit
• Patient whose prognosis is three months or less life expectancy
• Patient treated with step 3 opioids
• Pain experienced during care procedures and refractory to transmucosal fentanyl and equimolar mixture of oxygen and nitrous oxide if the latter is not contraindicated
• The pain scales used are Numeric Rating Scale ≥ 3/10 for patients able to communicate and Algoplus scale \> 2 for patients with inability to communicate verbally
• Indication of procedural sedation is agreed upon after collegial consultation and evaluation of the benefit risk balance (principle of double effect)
• Age: 18 and above
• Patient must be registered for social security
• Consent must be signed before and by the conscious patient or by his or her trusted person or relative for patients with cognitive impairments or disturbed vigilance

You may not qualify if:

• contra-indication to soya
• contra-indication to egg lecithin
• Respiratory insufficiency

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, 06200, France

Location

MeSH Terms

Conditions

Pain, Intractable

Interventions

Propofol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Flora TREMELLAT, MD

  Unité de Soins Palliatifs, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: May 19, 2017
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: June 4, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)